A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
Phase 1
Not yet recruiting
- Conditions
- HealthyOverweightType 2 DiabetesObesity
- Interventions
- Drug: LY4086940Drug: Placebo
- Registration Number
- NCT06945419
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.
Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 9 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
- Have no significant body weight change for the 3 months prior to screening
Part A:
- Are considered healthy
- Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening
Part B:
- Have a BMI of 27 to 45 kg/m2 at screening
Part C:
- Have a BMI of 25 to 45 kg/m2 at screening
Part D:
- Have type 2 diabetes
- Have hemoglobin A1C (HbA1c) ≥7.0% and ≤10.5% at screening
- Have a BMI of 27 to 45 kg/m2 at screening
Exclusion Criteria
- Have had an acute cardiovascular condition within the past 6 months prior to screening
- Have liver disease or pancreatitis
- Have used medications for weight loss within the 3 months prior to screening
Parts A, B, C:
- Have any form of diabetes
Part D:
- Have type 1 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: LY4086940 Single Dose (Healthy Participants) LY4086940 Participants will receive a single dose of LY4086940 orally Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) Placebo Participants will receive placebo orally for 4 weeks Part A: Placebo Single Dose (Healthy Participants) Placebo Participants will receive a single dose of placebo orally Part B: Placebo Multiple Dose (Participants with Overweight or Obesity) Placebo Participants will receive placebo orally for 4 weeks Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity) LY4086940 Participants will receive LY4086940 orally for 4 weeks Part A: LY4086940 Multiple Dose (Healthy Participants) LY4086940 Participants will receive LY4086940 orally for 3 days Part A: Placebo Multiple Dose (Healthy Participants) Placebo Participants will receive placebo orally for 3 days Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity) LY4086940 Participants will receive LY4086940 orally for 4 weeks Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity Placebo Participants will receive placebo orally for 4 weeks Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) LY4086940 Participants will receive LY4086940 orally for 4 weeks
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration Baseline through Week 15
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940 Predose up to Day 63 PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940 Predose up to Day 63
Trial Locations
- Locations (3)
Fortrea Clinical Research Unit
🇺🇸Dallas, Texas, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Lilly Centre for Clinical Pharmacology
🇸🇬Singapore, Singapore